drugset / Trial / NCT06719986

Pharmacodynamic Evaluation of Intramuscular Nalmefene Autoinjector 1.5 mg Compared to Intranasal Narcan 4 mg

NCT06719986

Phase 1 Completed 24 enrolled Purdue Pharma LP
RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study is to determine the pharmacodynamics (change in minute ventilation) of nalmefene when given as an autoinjector intramuscularly (IM; into the thigh) compared to naloxone when given intranasally (IN; into the nose) to healthy subjects with prior opioid exposure under steady state fentanyl concentrations (opioid agonism).

Timeline

Start
2022-10-03
Primary completion
2022-12-23
Completion
2022-12-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Nalmefene Small molecule 1.5 mg Intramuscular
Comparator Naloxone Small molecule 4 mg Intranasal